oramed pharmaceutical announced that it is considering restarting a Phase 3 trial of its oral insulin candidate in type 2 diabetes (T2D) after a previous pivotal trial failed to meet its endpoint.
In a letter to shareholders, the company said that following the previous failure of its oral insulin candidate ORMD-0801 candidate in clinical trials conducted in the United States in January 2023, the company has reviewed the candidate’s clinical trial data thoroughly. It has been revealed that the study has been completed. (NCT04606576).
This review revealed that subpopulations of patients within certain parameters such as body mass index (BMI), baseline hemoglobin A1C (HbA1c), and age respond well to oral insulin. These patients showed a statistically significant decrease in her HbA1c.
As a result of the analysis, the company has begun discussions with the U.S. Food and Drug Administration (FDA) and plans to begin a Phase III trial of the candidate in the U.S. using a revised protocol later this year.
ORMD-0801 is an insulin receptor agonist. Insulin works by binding to insulin receptors, lowering blood sugar levels.
Contains oramed Joint venture partnership with China-based Hefei Tianhui Biotechnology (HTIT). HTIT recently completed a Phase III trial of its oral insulin in China and is in the final stages of regulatory approval.
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Oramed said it expects the deal will help it complete newly announced Phase III clinical trials in the United States and leverage production capacity.
Current status of type 2 diabetes
of Strong in T2D field both and novo nordisk Eli Lilly currently has the lead in glucagon-like peptide-1 receptor agonist (GLP1Ra) drugs. According to GlobalData, Novo Nordisk is the market leader in this sector, with a value market share of 65.2%.
Novo Nordisk’s top candidate is semaglutide, sold as Ozempic, which GlobalData predicts global sales of $44 billion in 2029.
Meanwhile, Eli Lilly’s lead candidate tirzepatide, sold as Mounjaro, is expected to have global sales of $33.4 billion in 2029.
Both candidates are also approved for use in bariatrics under the names: wegobee and zep bound Each. Their sales forecasts include this market.
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